Postoperative Pulmonary ComplicationsNCT06023017
The Effect of Preoperative Prone Position Training on PPCs in Patients Undergoing Laparoscopic Sleeve Gastrectomy
A study testing Prone Position Training and standard perioperative care without any prone position training in people with Postoperative Pulmonary Complications, run by Min Su at 1 site in China.
Trial summary
Postoperative pulmonary complications(PPCs) is a common complication in patients undergoing surgery under general anesthesia, particularly in obese patients. Relevant studies have shown that PPCs are more common in patients undergoing laparoscopic sleeve gastrectomy, which contribute to significant increases in… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Pulmonary Complications
- What is being tested?
- Prone Position Training and standard perioperative care without any prone position training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 78 participants
- Where
- 1 siteChina
- Study dates
- 15 Sep 2023to 31 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age over 18 years old
- Body mass index(BMI)≥30 kg/m2
- Clinical diagnosis of metabolic syndrome, and undergoing Laparoscopic Sleeve Gastrectomy
Who cannot join
- Emergency surgery
- Cognitive dysfunction
- American Society of Anesthesiologists class ≥ IV
- Fractures (face, collarbone, ribs, spine, limbs)
- History of spontaneous pneumothorax
- Increased intracranial pressure
Show all 11Show fewer
- pregnancy
- Systemic infection
- Patients with hemodynamic instability
- Other conditions that are not suitable for prone position
- Failure to obtain informed consent
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Chongqing Medical University
Chongqing
Dong Zhang, Master, +86-023-89011069, 848138113@qq.com
About this study
Official title: The Effect of Preoperative Prone Position Training on Postoperative Pulmonary Complications in Patients Undergoing Laparoscopic Sleeve Gastrectomy
Postoperative pulmonary complications(PPCs) is a common complication in patients undergoing surgery under general anesthesia, particularly in obese patients. Relevant studies have shown that PPCs are more common in patients undergoing laparoscopic sleeve gastrectomy, which contribute to significant increases in morbidity, mortality, length of postoperative hospital stay and medical consumption. According to some reports, the incidence of PPCs in obese patients after abdominal surgery is about 40%. The reduction in pulmonary volume and respiratory muscular activation after major abdominal surgery due to surgery-related shallow breathing, pain, longterm bed rest, mucociliary clearance disorder, and diaphragmatic dysfunction may be the main causes of PPCs.
Numerous studies have demonstrated physiological improvement related to prone positioning. Prone positioning consists of placing a patient face down. Prone positioning has been used for to improve oxygenation in patients who require invasive mechanical ventilation for acute respiratory distress syndrome (ARDS). It has also been applied to non-intubated patients with acute respiratory failure (ARF), to improve oxygenation and delay or even avoid the need for invasive ventilation. So, the purpose of this study is to observe whether preoperative prone position training can reduce the incidence of pulmonary complications after laparoscopic sleeve gastrectomy.
Read the detailed description
Postoperative pulmonary complications(PPCs) is a common complication in patients undergoing surgery under general anesthesia, particularly in obese patients. PPCs refer to the clinical abnormal changes in the lungs after surgery, These include lung infections (pneumonia), atelectasis, pleural effusion, bronchospasm, acute respiratory failure or acute respiratory distress syndrome (ARDS). Postoperative atelectasis could last for more than 24h and contribute to a variety of other complications, including hypoxemia and pneumonia. Relevant studies have shown that PPCs are more common in patients undergoing laparoscopic sleeve gastrectomy, which contribute to significant increases in morbidity, mortality, length of postoperative hospital stay and medical consumption. According to some reports, the incidence of PPCs in obese patients after abdominal surgery is about 40%，and our hospital preliminary investigation, the incidence of PPCs in patients undergoing laparoscopic sleeve gastrectomy is approximately 30%. The reduction in pulmonary volume and respiratory muscular activation after major abdominal surgery due to surgery-related shallow breathing, pain, longterm bed rest, mucociliary clearance disorder, and diaphragmatic dysfunction may be the main causes of PPCs.
Numerous studies have demonstrated physiological improvement related to prone positioning. Prone positioning consists of placing a patient face down. Prone positioning has been used for to improve oxygenation in patients who require invasive mechanical ventilation for acute respiratory distress syndrome (ARDS). It has also been applied to non-intubated patients with acute respiratory failure (ARF), to improve oxygenation and delay or even avoid the need for invasive ventilation.
Currently, the mechanisms of prone position training are decreased lung compression in the gravity dependant zone,homogenisation of transpulmonary pressure, improvement of ventilation/perfusion ratio, and reduction of ventilator-induced lung injury (VILI) or patient self-inflicted lung injury (P-SILI). By placing the patient in the prone position, the lungs compression due to its own weight is reduced via a gravitational-dependent redistribution of fluids. In addition,the weight of the mediastinum is supported by the sternum, the stiffer part of the chest. At the same time, the diaphragm is displaced caudally, decreasing compression of the posterior-caudal lung parenchyma. Finally, in a triangular-shaped lung, more parenchyma is included in the dorsal half than in the ventral one resulting in a more aerated lung in prone positioning.
So, the purpose of this study is to observe whether preoperative prone position training can reduce the incidence of PPCs after laparoscopic sleeve gastrectomy.
This study was approved by the institutional review board of the First Affiliated Hospital of Chongqing Medical University. The protocol design is in accordance with Consolidated Standards of Reporting Trials (CONSORT) statement. All potentially eligible participants will be asked to give written informed consent before they are enrolled in this study. This study is a prospective, randomized, controlled clinical trial guided by the standard of good clinical practice (GCP),and eligible participants are divided into two groups: group PPT and group C,and primary assess the incidence of PPCs after laparoscopic sleeve gastrectomy
- Conditions
- Postoperative Pulmonary Complications
- Being tested
- Prone Position Training, standard perioperative care without any prone position training
- Keywords
- pulmonary complications, prone position,sleeve gastrectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prone Position TrainingBehavioural
All patients were admitted to our hospital at least 3 days before surgery. Patients in the intervention group (PPT group) received the prone position training daily in the hospital, three times a day, and about 1 hours every times, for at least 3 days before surgery. On the day of admission to the hospital, the patients in the PPT group were instructed to perform prone position training by nurses who were previously trained by prone position training.
standard perioperative care without any prone position trainingBehavioural
Patients in the control group (C group) received standard perioperative care without any prone position training.
| Study group | Role | What they receive |
|---|---|---|
| Prone Position Training group (PPT group) | Experimental | All patients were admitted to our hospital at least 3 days before surgery. Patients in the intervention group (PPT group) received the prone position training daily in the hospital, three times a day, and about 1 hours every times, for at least 3 days before surgery. On the day of admission to the hospital, the patients in the PPT group were instructed to perform prone position training by nurses who were previously trained by prone position training. Receives: Behavioral: Prone Position Training |
| Control group (C group) | Placebo comparator | Patients in the control group (C group) received standard perioperative care without any prone position training. Receives: Behavioral: standard perioperative care without any prone position training |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of postoperative pulmonary complications(PPCs)
The PPCs included pneumonia, atelectasis, pleural effusion, respiratory failure, and unplanned intubations
Measured: 3 days after surgery
Secondary outcomes (4)
arterial partial pressure of oxygen (PaO2)
Based on the blood gas analysis
Measured: preoperatively prior to starting prone position training, entering the operating room, the first day after surgery, the second day after surgery, and the third day after surgery
arterial partial pressure of carbon dioxide (PaCO2)
Based on the blood gas analysis
Measured: preoperatively prior to starting prone position training, entering the operating room, the first day after surgery, the second day after surgery, and the third day after surgery
oxygenation index (OI)
Based on the blood gas analysis
Measured: preoperatively prior to starting prone position training, entering the operating room, the first day after surgery, the second day after surgery, and the third day after surgery
extubation time
extubation time in postanesthesia care unit(PACU)
Measured: 1 Day of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2023
- Study start15 Sep 2023 (estimated)
- Primary completion30 Sep 2024 (estimated)
- Study completion31 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Pulmonary ComplicationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Min Su
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Min Su, First Affiliated Hospital of Chongqing Medical University
- Investigators
- Su Min, MD, Principal investigator, First Affiliated Hospital of Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06023017
- Sponsor's protocol ID
- CQMUAZD2023-2
- Status last verified
- Aug 2023
- First submitted
- 29 Aug 2023
- Last updated
- 5 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Preoperative Prone Position Training on Postoperative Pulmonary Complications in Patients Undergoing Laparoscopic Sleeve Gastrectomy
- ClinicalTrials.gov ID
- NCT06023017
- Acronym / sponsor ID
- CQMUAZD2023-2
- Conditions
- Postoperative Pulmonary Complications
- Keywords
- pulmonary complications, prone position,sleeve gastrectomy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- Min SuUniversity, hospital or other
- Study start
- 15 Sep 2023 (estimated)
- Primary completion
- 30 Sep 2024 (estimated)
- Study completion
- 31 Oct 2024 (estimated)
- First posted
- 5 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Postoperative pulmonary complications(PPCs) is a common complication in patients undergoing surgery under general anesthesia, particularly in obese patients. Relevant studies have shown that PPCs are more common in patients undergoing laparoscopic sleeve gastrectomy, which contribute to significant increases in morbidity, mortality, length of postoperative hospital stay and medical consumption. According to some reports, the incidence of PPCs in obese patients after abdominal surgery is about 40%. The reduction in pulmonary volume and respiratory muscular activation after major abdominal surgery due to surgery-related shallow breathing, pain, longterm bed rest, mucociliary clearance disorder, and diaphragmatic dysfunction may be the main causes of PPCs.
Numerous studies have demonstrated physiological improvement related to prone positioning. Prone positioning consists of placing a patient face down. Prone positioning has been used for to improve oxygenation in patients who require invasive mechanical ventilation for acute respiratory distress syndrome (ARDS). It has also been applied to non-intubated patients with acute respiratory failure (ARF), to improve oxygenation and delay or even avoid the need for invasive ventilation. So, the purpose of this study is to observe whether preoperative prone position training can reduce the incidence of pulmonary complications after laparoscopic sleeve gastrectomy.
Detailed description
Postoperative pulmonary complications(PPCs) is a common complication in patients undergoing surgery under general anesthesia, particularly in obese patients. PPCs refer to the clinical abnormal changes in the lungs after surgery, These include lung infections (pneumonia), atelectasis, pleural effusion, bronchospasm, acute respiratory failure or acute respiratory distress syndrome (ARDS). Postoperative atelectasis could last for more than 24h and contribute to a variety of other complications, including hypoxemia and pneumonia. Relevant studies have shown that PPCs are more common in patients undergoing laparoscopic sleeve gastrectomy, which contribute to significant increases in morbidity, mortality, length of postoperative hospital stay and medical consumption. According to some reports, the incidence of PPCs in obese patients after abdominal surgery is about 40%，and our hospital preliminary investigation, the incidence of PPCs in patients undergoing laparoscopic sleeve gastrectomy is approximately 30%. The reduction in pulmonary volume and respiratory muscular activation after major abdominal surgery due to surgery-related shallow breathing, pain, longterm bed rest, mucociliary clearance disorder, and diaphragmatic dysfunction may be the main causes of PPCs.
Numerous studies have demonstrated physiological improvement related to prone positioning. Prone positioning consists of placing a patient face down. Prone positioning has been used for to improve oxygenation in patients who require invasive mechanical ventilation for acute respiratory distress syndrome (ARDS). It has also been applied to non-intubated patients with acute respiratory failure (ARF), to improve oxygenation and delay or even avoid the need for invasive ventilation.
Currently, the mechanisms of prone position training are decreased lung compression in the gravity dependant zone,homogenisation of transpulmonary pressure, improvement of ventilation/perfusion ratio, and reduction of ventilator-induced lung injury (VILI) or patient self-inflicted lung injury (P-SILI). By placing the patient in the prone position, the lungs compression due to its own weight is reduced via a gravitational-dependent redistribution of fluids. In addition,the weight of the mediastinum is supported by the sternum, the stiffer part of the chest. At the same time, the diaphragm is displaced caudally, decreasing compression of the posterior-caudal lung parenchyma. Finally, in a triangular-shaped lung, more parenchyma is included in the dorsal half than in the ventral one resulting in a more aerated lung in prone positioning.
So, the purpose of this study is to observe whether preoperative prone position training can reduce the incidence of PPCs after laparoscopic sleeve gastrectomy.
This study was approved by the institutional review board of the First Affiliated Hospital of Chongqing Medical University. The protocol design is in accordance with Consolidated Standards of Reporting Trials (CONSORT) statement. All potentially eligible participants will be asked to give written informed consent before they are enrolled in this study. This study is a prospective, randomized, controlled clinical trial guided by the standard of good clinical practice (GCP),and eligible participants are divided into two groups: group PPT and group C,and primary assess the incidence of PPCs after laparoscopic sleeve gastrectomy
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prone Position Training group (PPT group) | Experimental | Behavioral: Prone Position TrainingAll patients were admitted to our hospital at least 3 days before surgery. Patients in the intervention group (PPT group) received the prone position training daily in the hospital, three times a day, and about 1 hours every times, for at least 3 days before surgery. On the day of admission to the hospital, the patients in the PPT group were instructed to perform prone position training by nurses who were previously trained by prone position training. |
| Control group (C group) | Placebo comparator | Behavioral: standard perioperative care without any prone position trainingPatients in the control group (C group) received standard perioperative care without any prone position training. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age over 18 years old
- Body mass index(BMI)≥30 kg/m2
- Clinical diagnosis of metabolic syndrome, and undergoing Laparoscopic Sleeve Gastrectomy
Key exclusion criteria (11 listed)
- Emergency surgery
- Cognitive dysfunction
- American Society of Anesthesiologists class ≥ IV
- Fractures (face, collarbone, ribs, spine, limbs)
- History of spontaneous pneumothorax
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prone Position TrainingAll patients were admitted to our hospital at least 3 days before surgery. Patients in the intervention group (PPT group) received the prone position training daily in the hospital, three times a day, and about 1 hours every times, for at least 3 days before surgery. On the day of admission to the hospital, the patients in the PPT group were instructed to perform prone position training by nurses who were previously trained by prone position training. | Behavioural | Prone Position Training group (PPT group) |
| standard perioperative care without any prone position trainingPatients in the control group (C group) received standard perioperative care without any prone position training. | Behavioural | Control group (C group) |
Primary outcome
The incidence of postoperative pulmonary complications(PPCs)
Time frame: 3 days after surgery
The PPCs included pneumonia, atelectasis, pleural effusion, respiratory failure, and unplanned intubations
4 secondary outcomes
arterial partial pressure of oxygen (PaO2)
Time frame: preoperatively prior to starting prone position training, entering the operating room, the first day after surgery, the second day after surgery, and the third day after surgery
arterial partial pressure of carbon dioxide (PaCO2)
Time frame: preoperatively prior to starting prone position training, entering the operating room, the first day after surgery, the second day after surgery, and the third day after surgery
oxygenation index (OI)
Time frame: preoperatively prior to starting prone position training, entering the operating room, the first day after surgery, the second day after surgery, and the third day after surgery
extubation time
Time frame: 1 Day of surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Su Min, MD principal investigator
First Affiliated Hospital of Chongqing Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prone Position Training and standard perioperative care without any prone position training in people with Postoperative Pulmonary Complications, run by Min Su at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dong Zhang, Master (+86-023-89011069, 848138113@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of postoperative pulmonary complications(PPCs) (time frame: 3 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2023.